1. Cancer & Aging Research Group (CARG)
Lessons Learned from the U13 NIA-NCI Conference U13 (2012): Eligibility Criteria and Enrollment of Older Adults in Cancer Research
American Geriatrics Society
May 2, 2013
William Dale, MD, PhD
University of Chicago

2. General Issues of Eligibility for Cancer Research

3. Why Eligibility Requirements?
Define the population being studied
Protect patients from risk
Facilitate comparisons across studies
Minimize between-patient variability
Enable drug labeling

4. Impact of Eligibility Requirements: The “Goldilocks” Approach
Too broad
Patient safety (potentially) jeopardized
Population too heterogeneous to detect tx effect
Non cancer-related events may limit interpretation of cancer-related endpoints
Encourages retrospective subset analysis
Too narrow
Barrier to effective accrual
Results not able to be generalized
Patient selection may yield “optimistic” results
Molecularly-defined subsets may have different natural history from historical controls

5. Application to Older Adults

6. A Recent Example from the Alliance Coop Group
Phase III trial of combined oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) with or without cetuximab.
Suspended until additional safety precautions were implemented to address the increased toxicities seen with older age.

7. Need for Recruitment of Oldest-Old and Frail Adults into Trials
Consideration of trial design to capture data on patients not eligible for standard clinical trials (e.g. observational cohort studies)
Alternative dosing strategies
Extra safety precautions for those with comorbidities, functional losses, cognitive impairment, and frailty.
More consistent and earlier research collaboration between oncology and geriatrics researchers when designing trials is essential.
Inclusion of QOL and Functional End-points

8. Potential Barriers to Enrollment of Older Patients in Cancer Research
Patient Preference
Physician Bias
Social Support
Eligibility Criteria

9. Patient Attitudes to Trial Enrollment
Patient attitudes have not been shown to lower trial enrollment.
Do not view age as a reason for not enrolling.
Stated reasons for not participating in trials are similar between older and younger patients.
The majority of older patients report a positive attitude toward participation in clinical trials.
75% of patients 70+ years are willing to participate in clinical trials
Cesari M et al:. J Gerontol A Biol Sci Med Sci 59:242-8, 2004;

10. Physician Role in Trial Enrollment
Physicians’ recommendations are an important factor in patients’ likelihood of participation in trials
Physician bias is one the largest barriers to the enrollment of older patients.
Physicians may be wary of randomizing older patients to regimens viewed as overly toxic, and the laudable goal of avoiding toxicity can interfere with the recruitment of older patients.
Safety profiles can be complicated by issues of polypharmacy, since older patients are more likely to have multiple comorbidities for which they take other medications.
Age- and comorbidity-related changes in pharmacokinetics, pharmacodynamics, organ function, and drug toxicity add even more complexity.

11. Summary
Townsley CA et al, J Clin Oncol 23: , 2005.

12. Lessons from Geriatricized Emergency Departments

13. The Geriatric ED
Hwang & Morrison. J Am Geriatr Soc 55:1873–1876,2007.

14. NYT: For the Elderly, Emergency Rooms of Their Own

15. Needed Structural Changes
Sufficient time for Geriatric Assessments
Provide geriatrics-specific training to support staff
Exam rooms and equipment that accommodates older patients for assessments
Resources to facilitate/support caregivers and transportation
Allow for data collection from remote areas with technology to facilitate data collection

16. A Modest Proposal: It Is Time for Geriatric “Clinical Trial Suite”

17. SOCARE Clinic: Oncology-Embedded Geriatrics
Personnel
3 MDs
1 APN
Trainees (Fellows)
Social Work
Started in 2006
Collaboration
Aging Assessment
Research Hub

18. And Special Thanks… 18